Quetiapine
- Product NDC
- 63629-7116
- 11-digit product format
- 636297116
- Labeler code
- 63629
- Product ID
- 63629-7116_e4115f00-9922-479a-9523-391357dd406d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202152
- Marketing category
- ANDA
- Marketing start
- 2012-03-28
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 616483 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-7116-1 | Quetiapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 106 |
| 63629-7116-2 | Quetiapine | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 106 |
| 63629-7116-3 | Quetiapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 106 |
| 63629-7116-4 | Quetiapine | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 106 |
| 63629-7116-5 | Quetiapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7116 | QUETIAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 5 package rows | 20240820_cb989abf-7d73-4ab9-a07f-a8c9de50389f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-7116-1 | 63629711601 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-7116-1) | 2016-10-17 | 0000-00-00 | No | No | Current |
| 63629-7116-2 | 63629711602 | 28 TABLET, FILM COATED in 1 BOTTLE (63629-7116-2) | 2024-08-08 | 0000-00-00 | No | No | Current |
| 63629-7116-3 | 63629711603 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-7116-3) | 2017-09-19 | 0000-00-00 | No | No | Current |
| 63629-7116-4 | 63629711604 | 180 TABLET, FILM COATED in 1 BOTTLE (63629-7116-4) | 2017-12-18 | 0000-00-00 | No | No | Current |
| 63629-7116-5 | 63629711605 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-7116-5) | 2024-08-08 | 0000-00-00 | No | No | Current |